The postage of contaminated medical

devices

Joanna Ford & Peter Phillips, SMTL

June 15th 2015

Introduction

SMTL receives defective disposable medical devices from Trusts all over Wales. This enables defects to be recorded centrally and investigated. In addition, it enables the Welsh NHS to inform manufacturers of potential problems with product manufacturing or design.

As these medical devices are often found to be defective during use on or in a patient, they are often contaminated with body fluids. Ideally, hospitals should decontaminate the medical device before sending it to SMTL for investigation. However, this is not always possible as the decontamination process may destroy useful information about the incident. Therefore, it is sometimes necessary for contaminated devices to be sent to SMTL from hospitals throughout Wales.

The sender of the item is responsible for making the package safe for those who transport, receive and open it and must adhere to relevant legislation which regulates the transport of such items. This report summarises advice about how contaminated devices can be appropriately transported.

Background Legislation

The legislation surrounding the transport of dangerous goods has been produced by the United Nations Economic Commission for Europe (UNECE 2012) and the HSE (HSE). They include details on the following:

Classification of dangerous goods

Specifications of packaging such as package composition

Packing instructions

Laboratory tests which must be passed for packaging to be approved

Correct labelling of packages

Specimen definition

The main categories that these devices potentially fall into include:

Infectious substances

substances 'reasonably known' to contain a pathogen

Infectious substances are classified into particular risk groups.

Medical or clinical waste

'low probability of pathogens being present' and

'materials are waste products derived from research or the medical treatment of humans or animals'

Diagnostic substances

'human or animal materials that are being transported only for the purpose of diagnosis or investigation'

*Packing instructions are slightly different depending on the hazard category of the package, but they include a triple packaging system with leak-proof containers containing absorbant material and labelling with the appropriate UN number. For more detail on individual packing instructions please see the HSE 'Carriage of dangerous goods' manual.

Issues surrounding specimen definition

One difficulty in establishing the correct procedure for packaging and transport of contaminated defects is that they do not fit clearly into any of the above categories. Specific issues are:

Although there is a potential risk of infection, the risk is unknown and therefore cannot be assigned to a 'risk' category which lists specific pathogens.

Although the device itself is being sent for investigation/diagnostic purposes and the contamination could be described as medical waste, it does not clearly fit into either the 'diagnostic' or 'medical waste' category.

Advice

MHRA

The MHRA's (Medical and Health care products Regulatory Agency) view is that 'it is illegal to send contaminated items through the post' (MHRA 2014). They state:

'Devices intended for single-use only do not require decontamination, except where they are implicated in an adverse incident and may need to be sent to the manufacturer for investigation. In this situation, contact the manufacturer to find out the most appropriate method of decontamination.' section 9 pg 44 (MHRA 2014).

Smithers PIRA (consultants for package industry)

A member of PIRA consultancy suggested that the contaminated medical devices received could be classified as diagnostic specimens (UN3373) and that they could be sent by Royal Mail using the Safebox or other packaging which is in accordance with p650 packaging specifications (information provided in 2008). When we contacted a member of PIRA (now Smithers Pira) in 2015 for an update, they were unable to provide any further information.

Royal Mail

A member of the Dangerous Goods Team at Royal Mail was contacted in March 2015. They stated

'I can advise that the equipment you wish to send through our network would be fine as they would come under our Biological substances guidelines.... The parcel has to follow the packaging guidelines 650 for this to be processed'.

Following Royal Mail's packaging guidelines:

the package may only be sent by, or at the specific request of, a qualified medical practitioner, registered dental practitioner, veterinary surgeon, registered nurse or a recognised laboratory or institution;

the total sample volume/mass in any parcel must not exceed 50ml/50g;

all biological substances must be posted in packaging that complies with Packaging Instruction 650, such as Royal Mail's Safebox product (Royal Mail Safebox).

DGP Intelsius

DGP Intelsius provides packaging for 'possibly infectious' and 'diagnostic' items (such as the PathoShield 4a or 4b). The company representative we discussed this with suggested that categorising contaminated items as 'infectious' may be 'over cautious' and indicated that the UN3373 (PathoShield 4b) labelled packages would be appropriate in most cases.

Conclusion

As a result of the feedback that has been received from experts in their fields and SMTL's experience in this area, our conclusion is that in most cases it is acceptable to classify contaminated devices as 'diagnostic' (UN3373) packages.

As a result of these investigations, the following recommendations have been devised for NHS staff in Wales to follow when they wish to send a medical device to SMTL:

If the device is not contaminated:

devices may be posted to SMTL with relevant paperwork

If the device is contaminated and can be decontaminated locally:

decontaminate the device using cold sterilant (seek advice locally from health and safety advisor or other appropriate personnel), package appropriately and post to SMTL with relevant paper work and a decontamination certificate

If the device is contaminated and it is not possible for the device to be decontaminated locally or there are concerns that decontamination could destroy important evidence, package appropriately and follow one of the 4 options below:

organise transfer of the package to SMTL via the hospital transport system (contact hotel services, post room, pharmacies or HSDU/CSSD for more details about local hospital transport arrangements)

pass on to a member of SMTL staff during a meeting (SMTL staff attend regular meetings with other NHS staff throughout Wales and devices could be exchanged during these ocassions)

send to SMTL via UN approved courier:

Royal Mail have stated that they will transport small items (weighing 50g or less) including contaminated medical devices. The Royal Mail's 'safebox' system can be used for this purpose and price includes cost of package and postage (Tel. 0845 778 2677).